Consumer medicine information

What you should know about your nose

Mucus is naturally produced in the nose and its role is to trap foreign particles (dust, viruses and bacteria) and keep them from getting into the lungs. Mucus is transported from the front of the nose and from within the sinuses by tiny microscopic hairs called "cilia" which sweep the mucus to the back of the throat from where it is swallowed.

The acid environment in the stomach then helps to kill unwanted bacteria and viruses. This is an important function of the body's immune system and it helps to maintain good health.

What happens when the mucus layer becomes dry?

When mucus dries out it becomes thicker and the cilia hairs cannot function as well as they should. Mucus may become crusty causing a feeling of nasal discomfort.

Travelling in low humidity and cool environments

Spending prolonged periods of time in low humidity and cool environments (such as aircraft cabins, buses, trains and hotels with air conditioning) has been shown to dry nasal mucus and slow the normal movement of mucus. This can result in an impaired immune function and travellers getting colds more easily than they would otherwise do.

What is FLO Travel Nasal Spray?

FLO Travel Nasal Spray is a sterile, preservative free, non-stinging saline spray containing Carrageenan 1.6mg /ml. It is aclear, colourless and odourless solution.

Carrageenan is an extract derived from marine red algae. Carrageenan binds effectively to mucus and strongly attracts water. This helps keep the nasal tissues moist to prevent and relieve symptoms of nasal crusting and discomfort that can be experienced on long distance flights, and importantly also helps nasal tissue to function normally to keep you healthy.

In the event of contracting a cold, Carrageenan has been shown to help reduce the length of time cold symptoms are experienced. This can be an added advantage when travelling.

How to use FLO Travel Nasal Spray

This dispenser should be used by only one person. Sharing it may spread infection.

1. Before using this product, remove the protective cap and prime the pump by depressing the round flange several times until the first spray is seen.
2. Place the nozzle carefully into one nostril with the tip pointing towards the top of the ear on the same side of the head (the tip should be pointing backwards and slightly angled away from the midline of the nose).
3. Depress the pump to insert the required dose into the nostril while gently breathing in through the nose as you spray.
4. Repeat for the other nostril.
5. Wipe the nozzle with a clean tissue and replace protective cap after use.
6. Store this product out of the sight and reach of children.

Dosage

Dose to be applied to each nostril:

• Adults and children over 12 years: up to two sprays three times daily.
• Children over 2 years of age: one spray three times daily.

This product may be used:

a)before, during and after travel.

b)more frequently if required to relieve nasal dryness and crusting.

Always drink adequate fluids and remember to take part in recommended exercise programmes on long journeys.

Pregnancy and Breast Feeding

FLO Travel is non-medicated and can be used during pregnancy and whilst breast feeding.

How long can FLO Travel be used?

FLO Travel nasal spray may be used for as long as necessary.

If nasal symptoms persist see your healthcare practitioner.

When not to use FLO Travel Nasal Spray

You should not use FLO Travel if you have any sensitivity to sodium chloride or Carrageenan. If you experience any unexpected effects such as a nose bleed, nasal irritation or nasal congestion when using this product, stop using it and see your healthcare practitioner.

When does FLO Travel expire?

FLO Travel has an expiry date which can be found on the carton and also on the bottle label. Do not use the product after this expiry date.

Due to its special filter system, the solution remains sterile even after repeated use.

Discard 12 months after date of first use.

Can FLO Travel be used with other medication?

FLO Travel is non-medicated and can be used in combination with other nasal medication.

It is recommended to use FLO Travel 20 minutes after the administration of any medicated nasal spray.

Packaging and Storage

FLO Travel Nasal Spray is packaged in a dark brown glass bottle containing 20mL of solution. Each spray delivers 0.14mL of solution.

The outer carton is sealed with tabs on the top and bottom flaps. You should not use this product if any of these tabs have been removed or damaged at the time of purchase.

Store the product in its carton to protect it from light.

Store the product below 30°C. Do not refrigerate.

Keep it out of the sight and reach of children.

For more information, contact:

ENT Technologies Pty Ltd
Suite 304, 12 Cato Street
Hawthorn East, VIC 3123. Australia.
Phone +61 3 9832 3700 or local call 1300 857 912
www.flo.com.au

Manufacturer: Hälsa Pharma GmbH
Maria-Goeppert- Straẞe 5, 23562 Lübeck. GERMANY.

Last update January 2020.

Published by MIMS May 2020

Name of the medicine

Carrageenan in sterile physiological saline.

Description

Flo Travel nasal spray contains 1.6 mg/mL of carrageenan in sterile physiological saline.

Pharmacology

Carrageenan is an extract of red seaweed (Chondrus crispus) and consists of both iota and kappa forms. Both these types of carrageenan have gelling properties and have been used for many years in the food industry. Carrageenan is strongly anionic which accounts for its mucoadhesive properties. It is also very hygroscopic and strongly retains water.
Iota carrageenans have been shown to have antiviral properties against common cold viruses (rhinovirus, corona virus and influenza A)^1,2. They have been shown to shorten the duration of colds, to reduce the severity of symptoms and also the period of viral shedding.
Environments which are kept cool to cold and which have a low humidity are challenging to nasal mucosal function. Mucus has been demonstrated to thicken and cilial beat frequency to decrease. As a result mucociliary transport is delayed³. This may have deleterious effects on the antimicrobial efficacy of the upper airway. Thickened mucus can become crusty and uncomfortable for people exposed to these environments for prolonged periods of time. With the added microbial pressures of close confines with other passengers or workers viral infections may be experienced more frequently.
As a solution to address these issues, carrageenan offers topical protection for nasal mucosa as well as the added benefits of antiviral properties.

Indications

Flo Travel is indicated for the prevention and relief of nasal crusting and dryness when there is prolonged exposure to cold and low humidity environments. These are experienced on aeroplane journeys, in office and hotel environments and wherever air conditioning is in constant use. It may also be used to shorten the duration and severity of common cold symptoms.

Contraindications

1. Sensitivity to any of the ingredients (carrageenans or saline solutions).
2. Nasal congestion or irritation associated with use of Flo Travel.
3. If any of the tamper evident seals are missing or show evidence of tampering.

Precautions

Patients with a history of recurrent nose bleeds and those on anticoagulation medication. Iota carrageenan does have antithrombotic properties and could initiate epistaxis in these patients.

Use in pregnancy.

Use in lactation.

Interactions

Use with other medications.

Dosage and Administration

Dosage.

Adults and children over 12 years.

Children 2 years of age and older.

Method of use.

Presentation

Nasal spray (preservative free, colourless, tasteless sterile solution), 1.6 mg/mL, 20 mL (0.14 mL/spray): 1's (dark brown glass bottle).

Storage

Store between 5 and 30 degrees Celsius in the original outer packaging.
Do not refrigerate.
Keep out of sight and reach of children.

References

1. Review of Carrageenan based pharmaceutical biomaterials: Favourable physical features versus adverse biological effects. Liu J et al. Carbohydrate Polymers Vol 121(2015) pp 27-36.
2. Carrageenan nasal spray in virus confirmed common cold: individual patient data analysis of two randomised controlled trials. Koenighofer M et al Multidisciplinary Respiratory Medicine (2014) Vol 9; pp 57-69.
3. Exposure to cold and acute upper respiratory tract infection. Eccles R et al Rhinology (2015) Vol 53 pp 99-106.

Poison Schedule

Unscheduled.